- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03259451
Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain (rTMS-CIC)
Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain: Retrospective Study on a Cohort of 149 Patients at Rennes University Hospital, From January 2014 to December 2015
연구 개요
상세 설명
Neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of the general population and the effectiveness of current treatments often remains incomplete: only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach.
As early as the 1990s, stimulation of the motor cortex by implanted electrodes made it possible to successfully treat certain chronic refractory neuropathic pain. In 1995 it was reported that the application of repeated shocks by transcranial magnetic stimulation of the motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain.
This technique has proved its analgesic efficacy after an induction treatment over 5 days, in the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not responders and there is currently, Of predictive criteria for response. It seems important to continue studies on this non-medicinal, non-invasive therapy with no significant adverse effects.
연구 유형
연락처 및 위치
연구 장소
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Rennes, 프랑스, 35033
- CHU de Rennes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patient older than 18 years old with chronic neuropathic pain who are resistant to drug therapy for which treatment with rTMS is indicated between January 2014 and December 2015
Exclusion Criteria:
- Patient less than 18 years old
- Pregnant woman
- Non-neuropathic pain
- Pain <6 months
- Unbalanced epilepsy
- Patient with a contraindication for cerebral MRI (cochlear implant, ocular metallic foreign bodies, patient with a pacemaker, mechanical valve)
- Psychiatric pathology
- Person subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term
기간: Day 7
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Improvement of pain symptoms by at least 30% on the numerical scale
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Day 7
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Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)
기간: Month 1
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Improvement of pain symptoms by at least 30% on the numerical scale
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Month 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months)
기간: Month 6
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Persistence of at least 30% improvement in pain symptoms on a numerical scale at the end of the sixth month (M6)
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Month 6
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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